NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter R-420-006

GUDID 00850044399079

NORTH EAST SCIENTIFIC INC

Atherectomy laser system beam guide-catheter, peripheral
Primary Device ID00850044399079
NIH Device Record Key4c23f696-aba2-4fa4-a5be-02540e0ff5ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameNES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter
Version Model NumberR-420-006
Catalog NumberR-420-006
Company DUNS608625823
Company NameNORTH EAST SCIENTIFIC INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com
Phone2037562111
Emailsales@nescientific.com

Device Dimensions

Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French
Catheter Working Length150 Centimeter
Lumen/Inner Diameter0.018 Inch
Introducer Sheath Compatibilit6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100850044399079 [Primary]
HIBCCB227NRP3683 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QTFReprocessed Atherectomy Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-29
Device Publish Date2025-05-21

On-Brand Devices [NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter]

B227NRP3683R-420-006
00850044399079R-420-006

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